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Epilepsy drug warnings to add suicidal ideation.(NEWS)
The Food and Drug Administration has directed physicians to inform patients taking anticonvulsant medications that the drugs have the potential to increase suicidal thoughts and behavior. Families and caregivers should also be notified of this risk so that they can be attuned to changes in behavior in patients receiving antiepileptic medications, according to the FDA's alert for health care professionals.
Based on an agency review of nearly 200 clinical trials of 11 antiepileptic drugs, the directive coincided with an FDA announcement that manufacturers of any medication in the class will be required to add warnings about suicidal thoughts or behavior in prescribing information or labeling and to develop medication guides for patients.
Revised labeling or an explanation "why they do not believe such labeling changes are necessary" must be submitted to the agency within 30 days.
Jack Cox, a spokesman for Pfizer Inc., said in an interview his firm will comply with the order. "Pfizer will work closely with the FDA to update the labeling of our antiepileptic medications Lyrica [pregabalin] and Neurontin [gabapentin], in a timely manner," he said.
"We have not heard directly from the FDA, but we will work to address any of the agency's concerns," said Tricia Geoghegan, a spokesperson for Ortho-McNeil Neurologics, makers of topiramate. Ms. Geoghegan noted that the label for Topamax (topiramate) has always included "content about this topic," but added that revisions will be made should the FDA request them.
The agency's decision drew on data from placebo-controlled clinical trials that enrolled a total of 43,892 patients aged 5 and older taking the medications for epilepsy, psychiatric disorders, and other conditions.
The FDA meta-analytic review of 199 trials determined that patients receiving antiepileptic drugs were at a twofold risk of suicidal behavior or thoughts (0.43%), compared with patients receiving placebo (0.24%). The difference translates to 1 additional case of suicidality per 530 patients treated with antiepileptic drugs.
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Source: HighBeam Research, Epilepsy drug warnings to add suicidal ideation.(NEWS)